5 replies to this topic

[GMP Packaging Industries]

Does anyone know if there is any text or recommendation for assuring safety and quality of packaging for the specific pharma sector?

[Simon]

PS 9000:2011
This Standard specifies GMP requirements and guidance within a quality management system (QMS) for suppliers of packaging materials and origination/artwork to the pharmaceutical industry and has been developed through collaboration between the pharmaceutical industry and its suppliers. The Standard provides an important reference text to assist medicinal product manufacturers and their suppliers in their understanding of their respective responsibilities in producing materials of the requisite quality, in order that the final product is fit for purpose.

[Nusa Blagotinsek]

Maybe also the ISO 1538:2011 can help you :)

[Simon]

Hi Nusa, is ISO 1538:2011 the correct reference number?

[Nusa Blagotinsek]

Hi, I am verry sorry, I ment ISO 15378

[Simon]

Quite correct Nusa.

 

 

ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

 

ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.